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Auris Medical治疗耳鸣新药Keyzilen临床III期研究宣告失败

2016-08-22 佚名 生物谷

耳鸣新药
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耳鸣是累及听觉系统的许多疾病不同病理变化的结果，病因复杂，机制不清，主要表现为无相应的外界声源或电刺激，而主观上在耳内或颅内有声音感觉。在临床上它既是许多疾病的伴发症状，也是一些严重疾病的首发症状（如听神经瘤）。这种疾病也给许多患者带来生活上的不变。由于其巨大的市场群体，许多生物医药公司也在开展治疗这种疾病的药物研究。最近，来自瑞士的生物医药公司Auris Medical宣布公司开发的治疗急性

耳鸣是累及听觉系统的许多疾病不同病理变化的结果，病因复杂，机制不清，主要表现为无相应的外界声源或电刺激，而主观上在耳内或颅内有声音感觉。在临床上它既是许多疾病的伴发症状，也是一些严重疾病的首发症状（如听神经瘤）。这种疾病也给许多患者带来生活上的不变。由于其巨大的市场群体，许多生物医药公司也在开展治疗这种疾病的药物研究。最近，来自瑞士的生物医药公司Auris Medical宣布公司开发的治疗急性内耳耳鸣的新药Keyzilen在一项临床研究中因未能达到首要终点而被迫宣告失败。

Keyzilen是一种含有盐酸氯胺酮的药物。盐酸氯胺酮是NMDA受体拮抗剂药物，研究人员认为这种药物能有有效改善耳鸣症状。Auris公司将其制成生物相容且可降解的凝胶药物，治疗时，这种凝胶药物通过鼓室注射的方式进入内耳，其有效成分扩散至耳蜗处从而达到治疗效果。遗憾的是，此次临床III期研究并未达到理想效果。研究人员设定的首要终点是药物能够在84天内显着改善患者的耳鸣症状。此次临床III期研究招募了超过600名症状程度不同的耳鸣患者。

尽管如此，公司仍然看好这一药物的未来，并希望今年进行的第二项临床研究中能为公司扳回一局。目前市面上并没有治疗耳鸣的药物，Auris公司希望该药物能够成为首个针对耳鸣的疗法。然而目前来看，此次临床III期研究失败的结果可能会给药物获批带来不小的麻烦。

耳鸣这一疾病虽然往往被人视为小毛病而加以忽略。但随着全球老龄化的加剧，这一问题也必然成为影响老年人健康和生活质量的一大问题。

原始出处：

Auris Medical off-target on tinnitus drug study

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    2017-01-07 juliusluan78

    #III#

    0

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    2016-12-04 HinsMax

    #III期研究#

    0

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    2017-04-12 jeanqiuqiu

    #DIC#

    0

  4. 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04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, 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    2016-09-18 ylzr123

    好文，从这里学习了好多新知识，新信息。赞了！

    0

  5. 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04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, 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    2016-08-26 ylzr123

    深度好文，赞一个！!！

    0

  6. 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04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, 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    2016-08-24 zhu_jun9837

    #耳鸣#

    0

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04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102461, encodeId=cff9102461ff, content=好好学习一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Tue Aug 23 06:58:00 CST 2016, time=2016-08-23, status=1, ipAttribution=)]
    2016-08-24 海豹

    #Medical#

    0

  8. 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encodeId=40361295e38bd, content=<a href='/topic/show?id=86158052809' target=_blank style='color:#2F92EE;'>#耳鸣#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80528, encryptionId=86158052809, topicName=耳鸣)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3609256, createdName=zhu_jun9837, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533545, encodeId=5eac1533545c6, content=<a href='/topic/show?id=7583114e529' target=_blank style='color:#2F92EE;'>#Medical#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11475, encryptionId=7583114e529, topicName=Medical)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cbe912466517, createdName=海豹, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102461, encodeId=cff9102461ff, content=好好学习一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Tue Aug 23 06:58:00 CST 2016, time=2016-08-23, status=1, ipAttribution=)]
    2016-08-24 智智灵药

    #III期#

    0

  9. 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encodeId=40361295e38bd, content=<a href='/topic/show?id=86158052809' target=_blank style='color:#2F92EE;'>#耳鸣#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80528, encryptionId=86158052809, topicName=耳鸣)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3609256, createdName=zhu_jun9837, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533545, encodeId=5eac1533545c6, content=<a href='/topic/show?id=7583114e529' target=_blank style='color:#2F92EE;'>#Medical#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11475, encryptionId=7583114e529, topicName=Medical)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cbe912466517, createdName=海豹, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102461, encodeId=cff9102461ff, content=好好学习一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Tue Aug 23 06:58:00 CST 2016, time=2016-08-23, status=1, ipAttribution=)]
    2016-08-24 ms3994565386320060

    #Med#

    0

  10. 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04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594454, encodeId=1340159445467, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1607058, encodeId=603e160e058b1, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Wed Aug 24 04:43:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=102461, encodeId=cff9102461ff, content=好好学习一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Tue Aug 23 06:58:00 CST 2016, time=2016-08-23, status=1, ipAttribution=)]
    2016-08-23 忠诚向上

    好好学习一下

    0

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